DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities: compound structure picture quality. The images of the compound structures recited in claim 1 are fuzzy and in the event the claim is deemed allowable the picture quality would be poor. Appropriate correction is required.
Claims 62 – 63 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 45 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 45 recites the compound according to claim 1 where the compound is selected from a list of compounds that include compounds 411 and 447. However, independent claim 1 does not recite either compound 411 or 447 in the claim. Since claim 45 is dependent on independent claim 1 but includes unrecited compounds 411 and 447; claim 45 expands the scope of claim 1 and fails to further limit claim 1. As a consequence claim 45 is rejected under 35 U.S.C. 112(d). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 45, and 48 – 50 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2020/142557 A1 to Butler et.al. (Butler’557; cited on the ISR form).
Regarding claims 1, 45, and 48 – 50, Butler’557 teach compounds, methods of making such compounds, pharmaceutical compositions and medicaments containing such compounds, and methods of using such compounds and compositions to inhibit the activity of menin-MLL. See page 1 paragraph 0001. Butler’557 teach some embodiments where the compound is according to Formula (I) of structure
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or a pharmaceutically acceptable salt thereof. See page 4 paragraph 0011. Specifically, Butler’557 teach an embodiment of a compound according to formula (XVI) of structure
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. See page 7 paragraph 0019. Thus, Butler’557 teach the racemate which includes both enantiomers. More specifically, Buttler’557 teach compound 10 example 9 of the structure
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one of the enantiomers of formula (XVI). See page 158 - 159 paragraph 00551. Moreover, Butler’557 teach that compounds of the disclosure, which includes the compound according to formula (XVI), can be provided in pharmaceutical compositions comprising a therapeutically effective amount of the compound and a pharmaceutically acceptable excipient. See page 7 paragraph 0023. See claim 48 limitation for a pharmaceutical composition comprising a compound according to claim 1 and a pharmaceutically acceptable excipient. Furthermore, Butler’557 teach that pharmaceutical compositions of the disclosure, which includes the compound according to formula (XVI), can formulated for a route of administration selected from oral administration, parenteral administration, buccal administration, nasal administration, topical administration, or rectal administration. See page 8 paragraph 0023. See claim 49 limitations for a pharmaceutical composition formulated for a route of administration selected from oral administration, parenteral administration, buccal administration, nasal administration, topical administration, or rectal administration. Additionally, Butler’557 teach a method for inhibiting Menin-MLL activity in a subject in need thereof by administering to the subject thereof a composition containing a therapeutically effective amount of at least one compound having the structure of Formula ( I), which includes the compound according to formula (XVI). Likewise, Butler’557 teach that in some embodiments, the subject in need is suffering from a list of diseases that includes diabetes. See page 10 paragraph 0038. See claim 50 limitations for a method of treating diabetes.
However, Butler’557 fails to teach compound 103 of structure
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. See claims 1 and 45.
Nevertheless, Buttler’557 teach compound 10 example 9 of the structure
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. See page 158 - 159 paragraph 00551. Prior art compound 10 differs from the examined claim 1 compound of 103 of structure
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by the structure of the amide bond between the phenyl ring and the pyridine ring. In prior art compound 10 the carbonyl of the amide bond is closest to the pyridine ring while in examined compound 103 the carbonyl is closest to the phenyl ring. Thus the only difference between Butler’557 compound 10 and the examined compound 103 is the position or orientation of the amide bond. Given that the only difference between Butler’557 compound 10 and the examined compound 103 is the position or orientation of the amide bond these compounds are positional isomers of each other. Therefore, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09(II).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 45, and 48 – 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 13, 16, and 23 – 25 of U.S. Patent No. US 11084825 B2 to Butler et. al. (Butler’825; cited on IDS) in view of International Publication Number WO 2020/142557 A1 to Butler et.al. (Butler’557; cited on the ISR form).
Butler’825 recite a compound according to formula (I) of structure
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or a pharmaceutically acceptable salt thereof. See reference claim 1. Particularly, Butler’825 recite a compound according to formula (XVI) of structure
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. See reference claim 2 – 13, and 16. Moreover, Butler’825 recite a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a compound according to (reference) claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof. See reference claim 23. See examined claim 48. Furthermore, Butler’825 recite a pharmaceutical composition where the pharmaceutical composition is formulated for a route of administration selected from the group consisting of buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. See reference claim 24. See examined claim 49. Additionally, Butler’825 recite a method for inhibiting menin-MLL activity in a patient, comprising administering to the patient in need thereof a therapeutically effective amount of the pharmaceutical composition according to (reference) claim 23. See reference claim 25.
However, Butler’825 fails to recite a compound that is compound 103 of structure
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. See examined claims 1 and 45. Moreover, Butler’825 fails to recite a method or treating diabetes comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of (examined) claim 48. See examined claim 50.
Nevertheless Butler’825 recite a compound according to formula (XVI) of structure
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. See reference claim 2 – 13, and 16. The invention of Butler’825 differs from the examined claim 1 compound of 103 of structure
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by the structure of the amide bond between the phenyl ring and the pyridine ring. In the invention of Butler’825 the carbonyl of the amide bond is closest to the pyridine ring while in examined compound 103 the carbonyl is closest to the phenyl ring. Thus one of the only differences between the invention of Butler’825 and the examined compound 103 is the position or orientation of the amide bond. Given that the only difference between the invention of Butler’825 and the examined compound 103 is the position or orientation of the amide bond these compounds are positional isomers of each other. Therefore, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09(II).
However, Butler’825 fails to recite a compound that is compound 103 of structure
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where the amide bond on the end other molecule has the absolute configuration as shown. See examined claims 1 and 45. Moreover, Butler’825 fails to recite a method or treating diabetes comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of (examined) claim 48. See examined claim 50.
Nevertheless, the teachings of Butler’557 as they relate to claims prior art rejections of examined claims 1, 45, and 48 – 50 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the examined application to modify the invention of Butler’825 for a compound of structure
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in view of Butler’557, that is to select the isomer with the absolute configuration as claimed and the use the compound in a method of treating diabetes. One of ordinary skill in the art would have been motivated to make this modification since the amide bond could only exist in the wedged or dashed form. Moreover one of ordinary skill in the art would have been motivated to use the compound in a method of treating diabetes and have a reasonable expectation of success because the prior art taught that these compounds as Menin-MLLL inhibitors and diabetes can be treated by inhibiting the menin-MLL interaction.
Claims 1, 45, and 48 – 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 3 of U.S. Patent No. US 11702421 B2 to Butler et.al. (Butler’421; cited on IDS) in view of International Publication Number WO 2020/142557 A1 to Butler et.al. (Butler’557; cited on the ISR form).
Butler’421 recite a compound selected with the structure
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. See reference claims 1 and 3.
However, Butler’421 fails to recite a compound that is compound 103 of structure
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. See examined claims 1 and 45. Moreover, Butler’421 fails to recite a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a compound according to (examined) claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof. See examined claim 48. Furthermore, Butler’421 fails recite a pharmaceutical composition where the pharmaceutical composition is formulated for a route of administration selected from the group consisting of buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. See examined claim 49. Moreover, Butler’825 fails to recite a method or treating diabetes comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of (examined) claim 48. See examined claim 50.
Nevertheless Butler’421 recite a compound selected with the structure
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. See reference claims 1 and 3. The invention of Butler’421 differs from the examined claim 1 compound of 103 of structure
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by the structure of the amide bond between the phenyl ring and the pyridine ring. In the invention of Butler’421 the carbonyl of the amide bond is closest to the pyridine ring while in examined compound 103 the carbonyl is closest to the phenyl ring. Thus one of the only differences between the invention of Butler’421 and the examined compound 103 is the position or orientation of the amide bond. Given that the only difference between the invention of Butler’421 and the examined compound 103 is the position or orientation of the amide bond these compounds are positional isomers of each other. Therefore, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09(II).
However Butler’421 fails to recite a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a compound according to (examined) claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof. See examined claim 48. Furthermore, Butler’421 fails recite a pharmaceutical composition where the pharmaceutical composition is formulated for a route of administration selected from the group consisting of buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. See examined claim 49. Moreover, Butler’825 fails to recite a method or treating diabetes comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of (examined) claim 48. See examined claim 50.
Nevertheless, the teachings of Butler’557 as they relate to claims prior art rejections of examined claims 1, 45, and 48 – 50 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the examined application to modify the invention of Butler’421 for a compound of structure
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in view of Butler’557, that is to formulate the compound in a pharmaceutical composition capable of being administered through buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration and the use the compound in a method of treating diabetes. One of ordinary skill in the art would have been motivated to use the compound in a method of treating diabetes and have a reasonable expectation of success because the prior art taught that these compounds as Menin-MLLL inhibitors and diabetes can be treated by inhibiting the menin-MLL interaction.
Claims 1, 45, and 48 – 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 – 10, and 13 – 14 of U.S. Patent No. US 12116371 B2 to Butler et. al. (Butler’371; cited on the IDS) in view of International Publication Number WO 2020/142557 A1 to Butler et.al. (Butler’557; cited on the ISR form).
Butler’371 recite a compound that is
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or a pharmaceutically acceptable salt thereof. See reference claim 8. Moreover, Butler’371 recite a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a compound according to (reference) claim 8, or a pharmaceutically acceptable salt or stereoisomer thereof. See reference claim 9. See examined claim 48. Additionally, Butler’371 recite a method for inhibiting menin-MLL activity in a patient, comprising administering to the patient in need thereof a therapeutically effective amount of the pharmaceutical composition according to (reference) claim 8. See reference claim 10. Moreover, Butler’371 recite a method according to (reference) claim 10 where the patient has diabetes. See reference claims 13 – 14. See examined claim 50.
However, Butler’371 fails to recite a compound that is compound 103 of structure
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. See examined claims 1 and 45. Furthermore, Butler’371 fail to recite a pharmaceutical composition according to (examined) claim 48 where the pharmaceutical composition is formulated for a route of administration selected from the group consisting of buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. See examined claim 49.
Nevertheless, Butler’371 recite a compound that is
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or a pharmaceutically acceptable salt thereof. See reference claim 8. The invention of Butler’371 differs from the examined claim 1 compound of 103 of structure
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by the structure of the amide bond between the phenyl ring and the pyridine ring. In the invention of Butler’371 the carbonyl of the amide bond is closest to the pyridine ring while in examined compound 103 the carbonyl is closest to the phenyl ring. Thus one of the only differences between the invention of Butler’371 and the examined compound 103 is the position or orientation of the amide bond. Given that the only difference between the invention of Butler’371 and the examined compound 103 is the position or orientation of the amide bond these compounds are positional isomers of each other. Therefore, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09(II).
However, Butler’371 fail to recite a pharmaceutical composition according to (examined) claim 48 where the pharmaceutical composition is formulated for a route of administration selected from the group consisting of buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. See examined claim 49.
Nevertheless, the teachings of Butler’557 as they relate to claims prior art rejections of examined claims 1, 45, and 48 – 50 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the examined application to modify the invention of Butler’421 for a compound of structure
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in view of Butler’557, that is to formulate the compound in a pharmaceutical composition capable of being administered through buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. One of ordinary skill in the art would have been motivated to formulate the compound for different modes of administration and have a reasonable expectation of success because formulation in well known in the pharmaceutical arts. Moreover, given that the skill level of one of ordinary skill in the pharmaceutical arts is relatively high being that of a MD, PharmD, or PhD it would be within the purview of such artisan to know how to formulate the compound into different pharmaceutical forms for different modes of administration.
Claims 1, 45, and 48 – 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 21 of copending Application No. 19/340177 to Somanath et. al. (reference application; Somanath’177) in view of International Publication Number WO 2020/142557 A1 to Butler et.al. (Butler’557; cited on the ISR form).
Somanath’177 recite a compound according to Formula (I):
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N-[4-[4-(4-morpholinyl)-7H-pyrrolo[2,3-d]pyrimidin-6-yl]phenyl]-4-[[3(R)-[(1-oxo-2-propen-1-yl)amino]-1-piperidinyl]methyl]-2-pyridinecarboxamide, or a pharmaceutically acceptable salt thereof. See reference claims 1 and 7. Additionally, Somanath’177 recite a compound according to Formula (I):
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N-[4-[4-(4-morpholinyl)-7H-pyrrolo[2,3-d]pyrimidin-6-yl]phenyl]-4-[[3(S)-[(1-oxo-2-propen-1-yl)amino]-1-piperidinyl]methyl]-2-pyridinecarboxamide, or a pharmaceutically acceptable salt thereof. See reference claim 2. Furthermore, Somanath’177 recite the compound of (reference) claim 1 or 2 which is a different enantiomeric excess. See reference claims 3 – 4. Moreover, Somanath’177 recite a composition comprising a compound of the previous (reference) claims at different relative weights. See reference claim 5. Somanath’177 recite a pharmaceutical composition comprising a compound of the previous (reference) claims for oral administration comprising (a) about 10 mg to about 250 mg of any compound or composition of the previous claims; (b) about 50 wt% to about 80 wt% of one or more diluents; ( c) about 1 wt% to about 10 wt% of one or more disintegrating agents; (d) about 0.2 wt% to about 3 wt% of one or more glidants; and (e) about 0.2 wt% to about 1.0 wt% of one or more lubricants. See reference claims 8 – 21. See examined claims 48 – 49.
However, Somanath’177 fails to recite a compound that is compound 103 of structure
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. See examined claims 1 and 45. Moreover, Somanath’177 fails to recite a method or treating diabetes comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of (examined) claim 48. See examined claim 50.
Nevertheless, Somanath’177 recite a compound according to Formula (I):
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N-[4-[4-(4-morpholinyl)-7H-pyrrolo[2,3-d]pyrimidin-6-yl]phenyl]-4-[[3(R)-[(1-oxo-2-propen-1-yl)amino]-1-piperidinyl]methyl]-2-pyridinecarboxamide, or a pharmaceutically acceptable salt thereof. See reference claims 1 and 7. Copending Somanath’177 differs from the examined claim 1 compound of 103 of structure
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by the structure of the amide bond between the phenyl ring and the pyridine ring. In copending Somanath’177 the carbonyl of the amide bond is closest to the pyridine ring while in examined compound 103 the carbonyl is closest to the phenyl ring. Thus one of the only differences between copending Somanath’177 and examined compound 103 is the position or orientation of the amide bond. Given that the only difference between copending Somanath’177 and the examined compound 103 is the position or orientation of the amide bond these compounds are positional isomers of each other. Therefore, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09(II).
However, Somanath’177 fails to recite a method or treating diabetes comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of (examined) claim 48. See examined claim 50.
Nevertheless, the teachings of Butler’557 as they relate to claims prior art rejections of examined claims 1, 45, and 48 – 50 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the examined application to modify copending Somanath’177 for a compound of structure
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in view of Butler’557, that is to use the compound in a method of treating diabetes. One of ordinary skill in the art would have been motivated to use the compound in a method of treating diabetes and have a reasonable expectation of success because the prior art taught that these compounds as Menin-MLLL inhibitors and diabetes can be treated by inhibiting the menin-MLL interaction.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 45, and 48 – 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 127 – 132 of copending Application No. 18/768954 to Butler et. al. (reference application; Butler’954) in view of International Publication Number WO 2020/142557 A1 to Butler et.al. (Butler’557; cited on the ISR form).
Butler’954 recite a compound that is
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or a pharmaceutically acceptable salt thereof. See reference claims 127 – 128. Moreover, Butler’954 recite a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a compound according to (reference) claim 127, or a pharmaceutically acceptable salt or stereoisomer thereof. See reference claim 129. See examined claim 48. Additionally, Butler’954 recite a method according to (reference) claim 127 where the patient has diabetes. See reference claims 130 – 132. See examined claim 50.
However, Butler’954 fails to recite a compound that is compound 103 of structure
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. See examined claims 1 and 45. Furthermore, Butler’954 fail to recite a pharmaceutical composition according to (examined) claim 48 where the pharmaceutical composition is formulated for a route of administration selected from the group consisting of buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. See examined claim 49.
Nevertheless, Butler’954 recite a compound according to Formula (I):
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. See reference claim 127. Copending Butler’954 differs from the examined claim 1 compound of 103 of structure
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by the structure of the amide bond between the phenyl ring and the pyridine ring. In copending Butler’954 the carbonyl of the amide bond is closest to the pyridine ring while in examined compound 103 the carbonyl is closest to the phenyl ring. Thus one of the only differences between copending Butler’954 and examined compound 103 is the position or orientation of the amide bond. Given that the only difference between copending Butler’954 and the examined compound 103 is the position or orientation of the amide bond these compounds are positional isomers of each other. Therefore, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09(II).
However, Butler’954 fail to recite a pharmaceutical composition according to (examined) claim 48 where the pharmaceutical composition is formulated for a route of administration selected from the group consisting of buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. See examined claim 49.
Nevertheless, the teachings of Butler’557 as they relate to claims prior art rejections of examined claims 1, 45, and 48 – 50 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the examined application to modify the copending Butler’954 for a compound of structure
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in view of Butler’557, that is to formulate the compound in a pharmaceutical composition capable of being administered through buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. One of ordinary skill in the art would have been motivated to formulate the compound for different modes of administration and have a reasonable expectation of success because formulation in well known in the pharmaceutical arts. Moreover, given that the skill level of one of ordinary skill in the pharmaceutical arts is relatively high being that of a MD, PharmD, or PhD it would be within the purview of such artisan to know how to formulate the compound into different pharmaceutical forms for different modes of administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, and 45 – 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 – 10, 23, 25 – 27, 39, 46, 62, 66 – 68, and 81 – 83 of copending Application No. 19/489148 to Cao et.al. (reference application; Cao’148).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to compound according to formula (L-I):
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. In particular, Cao’148 recites compounds of formula (L-I), See reference claim 1. Moreover, Cao’148 further defines in (reference) dependent claims 8 – 10, 23, 25 – 27, 39, 46, 62, structural features that anticipate compounds of examined claims 1, and 45 – 47. Moreover, Cao’148 recite a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a compound according to (reference) claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof. See reference claim 67. See examined claim 48. Furthermore, Cao’148 recite a pharmaceutical composition where the pharmaceutical composition is formulated for a route of administration selected from the group consisting of buccal administration, nasal administration, oral administration, parenteral administration, rectal administration, and topical administration. See reference claim 68. See examined claim 49. Additionally, Cao’148 recite a method of treating diabetes mellitus in a mammal comprising administering to the mammal a pharmaceutical formulation according to (reference) claim 66. See reference claims 81 – 83. See examined claim 50.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, and 45 – 50 are rejected. Claims 62 – 63 are objected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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